Effects of Esketamine on Postoperative Pain, Anxiety and Depression in Patients Undergoing Tumor Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Although the acute and chronic postoperative pain of surgical patients has gradually been paid attention to, it has not yet been better resolved.and, the incidence of anxiety and depression in cancer patients is constantly increasing，The new analgesic anesthetic esketamine hydrochloride was launched in China last year，however, in the domestic and foreign literature, there are still few reports of esketamine hydrochloride in postoperative analgesia, and most of them are retrospective and small samples.This study aims to investigate whether esketamine has advantages over traditional opioids in terms of postoperative analgesia, anxiety and depression in cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Patients undergoing elective tumor surgery
- •Use intravenous analgesia pump (PCIA) after operation
排除标准
- •Patients with severe infection or respiratory system diseases;
- •Severe arrhythmia, unstable angina or myocardial infarction, heart failure;
- •Patients with severe diseases of liver, kidney, endocrine or immune system; ·Patients with fever before operation;
- •One month before operation Patients receiving chemotherapy, radiotherapy or immunotherapy;
- •Drug or alcohol dependence;
- •Mental illness, disturbance of consciousness and communication difficulties or inability to understand the questionnaire or refusal to complete;
- •Long-term use of antidepressant and anxiety drugs;
- •High intracranial pressure High intraocular pressure
研究组 & 干预措施
High-dose esketamine group
After the operation, 5 mg esketamine was injected intravenously for postoperative analgesia. PCIA formula: hydromorphone 6mg + esketamine 45mg + tropisetron 10mg into 0.9% sodium chloride injection 100ml, the first dose is 20ug/kg , Background dose 2ug/kg/h, single dose 4ug/kg/time
干预措施: High-dose Esketamine hydrochloride+Hydromorphone (Drug)
Low-dose esketamine group
After the operation, esketamine 2.5mg was injected intravenously for postoperative analgesia. PCIA formula: hydromorphone 6mg + esketamine 22.5mg + tropisetron 10mg into 0.9% sodium chloride injection 100ml, the first dose is 20ug/ kg, background dose 2ug/kg/h, single dose 4ug/kg/time
干预措施: Low-dose Esketamine hydrochloride+Hydromorphone (Drug)
Control group
PCIA formula: 6mg of hydromorphone + 10mg of tropisetron into 100ml of 0.9% sodium chloride injection, the first dose is 20ug/kg, the background dose is 2ug/kg/h, and the single dose is 4ug/kg/time.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Pain score
时间窗: Within 72 hours after surgery
Visual analog scale
Incidence of moderate to severe pain
时间窗: Within 72 hours after surgery
Visual analog score is 4 points or more
次要结局
- Sleep condition(Within 72 hours after surgery)
- Chronic pain(One month after surgery)
- Postoperative analgesia(Within 48 hours after surgery)
- Adverse reactions(Within 72 hours after surgery)
- Sedation(Within 48 hours after surgery)
- Anxiety(Baseline (Before operation), 24 hours after operation, 72 hours after operation)
- Depression(Baseline (Before operation), 24 hours after operation, 72 hours after operation)